Senior Medical Director

hace 4 días

Alcobendas, Madrid, España Parexel A tiempo completo
About the Role

Parexel is a leading biopharmaceutical services company that improves the world's health by transforming scientific discoveries into new treatments. We are seeking a highly experienced Senior Medical Director to join our team in the EMEA region.

Job Purpose

The Senior Medical Director will provide leadership and direction to the Safety Medical Sciences business functions and other assigned business functions. This role requires extensive experience in Pharmacovigilance / Drug Safety, team management, and the potential to grow into a bigger leadership role.

Key Responsibilities
  1. Represent the function/department at various internal and external forums.
  2. Contribute significantly to thought leadership activities.
  3. Responsible for resource management, overall quality, business continuity, utilization, and profitability.
  4. Maintain an excellent knowledge of the adverse event/safety profile of assigned products, labeling documents, data handling conventions, client's guidelines and procedures, and global drug safety regulations and guidelines.
  5. Maintain an excellent awareness of global regulatory requirements, reporting obligations, and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting.
  6. Attend, provide consultations, and/or present at client/cross-functional meetings along with other stakeholders.
  7. Overall responsible for the quality of the function and function's Key Performance Indicators (KPIs) targets.
  8. Work in collaboration with the Safety Services Leadership Team and provide strategic and competitive inputs to the department and organization.
  9. Perform medical review of cases not limited to (including non-serious and serious spontaneous, clinical trial, and literature cases including combination products drug-device) according to client/Parexel Standard Operating Procedures (SOPs) as applicable and liaising with the client, as required.
  10. Write Pharmacovigilance/Marketing Authorization Holder (MAH) comments and assess company causality.
  11. Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, and review narrative.
  12. Review and/or author aggregate reports for medical content and consistency in accordance with client requirements and SOPs.
  13. Review and sign off adverse events report for accuracy and clinical importance, relationship to the study drug as well as for severity and seriousness.
  14. Provide input as necessary to Feasibility Studies, Data Monitoring Committees (DMCs), Clinical Endpoint Committees (CECs).
  15. Perform signal detection activities in accordance with client conventions/SOPs and within pre-decided timeframes. Perform medical assessment of safety alerts obtained from data mining activities.
  16. Author/review Serious Adverse Event Reports (SERs). Perform case analysis, review literature summaries, and check draft for medical and scientific accuracy and cohesiveness.
  17. Author/review responses to Health Authority requests and other safety documents.
  18. Manage safety signals on project-specific tools (e.g., Signal Tracking System, Signal management tools, etc.).
  19. Contribute to Pharmacovigilance and Risk Management planning for designated products by preparation of safety surveillance strategy and highlighting and tracking potential issues.
  20. Prepare and review periodic safety reports (PBRER/PSUR, DSUR, European Union renewal, HHE and other Annual Safety/addendum reports) in accordance with regulatory requirements and SOPs.
  21. Support the preparation and maintenance of safety sections of the Company Core Data Sheet, local labels, and Development Core Safety Information (DSCI).
  22. Provide safety content review of clinical protocols, study reports, Investigators Brochures, and other related documents.
  23. Contribute to regulatory agency submissions (Investigational New Drug applications, New Drug applications, Marketing Authorization applications, Variations, and Renewals) by reviewing safety data and preparing relevant sections of the filing documents and submission packages.
  24. Participate in or provide input for Drug Safety Monitoring Boards or independent monitoring committee meetings, as applicable.
  25. Ensure alignment of Therapeutic Area objectives, safety strategies, and issue escalation with Pharmacovigilance.
  26. Oversee continuous evaluation of safety and benefit-risk assessment activities and strategies for the Therapeutic Area.
  27. Support other therapeutic area teams and deputize for the PV Head if required.
Requirements
  • Extensive drug safety and clinical trial knowledge and experience.
  • Clinical practice experience.
  • Managerial and Leadership experience is a must.
  • Very strong knowledge/understanding of medical terminology.
Education
  • Doctor of Medicine (MD) / Medically qualified from an acknowledged Medical School.
  • Completion of at least a basic training in clinical medicine (residency, internship, etc.).

  • Medical Director

    hace 3 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a Medical Director / Senior Medical Director with a strong background in Gastroenterology to join our team. As a medical expert with specialized therapeutic expertise, you will be responsible for initiating and maintaining medical and consultative relationships with clients, consulting on early engagement and pre-award...

  • Medical Director

    hace 4 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a Medical Director / Senior Medical Director with a strong background in Gastroenterology to join our team. As a medical expert with specialized therapeutic expertise, you will be responsible for initiating and maintaining medical and consultative relationships with clients, consulting on early engagement and pre-award...

  • Senior Medical Director, Gastrointestinal Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director to join our team. As a Medical Director, you will be responsible for providing medical expertise and leadership to our clients across the globe.Key ResponsibilitiesProject Execution: Deliver medical support for successful project delivery, including medical monitoring and pharmacovigilance...

  • Senior Medical Director, Gastrointestinal Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director to join our team. As a Medical Director, you will be responsible for providing medical expertise and leadership to our clients across the globe.Key ResponsibilitiesProject Execution: Deliver medical support for successful project delivery, including medical monitoring and pharmacovigilance...

  • Medical Director, Gastrointestinal Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job SummaryParexel is seeking a highly skilled Medical Director / Senior Medical Director with a strong background in Gastroenterology to join our team. As a medical expert with specialized therapeutic expertise, you will be responsible for initiating and maintaining medical and consultative relationships with clients, consulting on early engagement and...

  • Medical Director, Gastrointestinal Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job SummaryParexel is seeking a highly skilled Medical Director / Senior Medical Director with a strong background in Gastroenterology to join our team. As a medical expert with specialized therapeutic expertise, you will be responsible for initiating and maintaining medical and consultative relationships with clients, consulting on early engagement and...

  • Senior Medical Director

    hace 1 semana

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job SummaryParexel is a leading biopharmaceutical services company that improves the world's health by transforming scientific discoveries into new treatments. We are seeking a highly experienced Senior Medical Director to lead our Safety Medical Sciences business functions and provide strategic inputs to Safety Services Leadership.Key...

  • Senior Medical Director

    hace 1 semana

    Alcobendas, Madrid, España Parexel A tiempo completo

    Job SummaryParexel is a leading biopharmaceutical services company that improves the world's health by transforming scientific discoveries into new treatments. We are seeking a highly experienced Senior Medical Director to lead our Safety Medical Sciences business functions and provide strategic inputs to Safety Services Leadership.Key...

  • Senior Medical Director

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly experienced Senior Medical Director to lead our Safety Medical Sciences business functions and provide strategic inputs to Safety Services Leadership. As a key member of our team, you will be responsible for implementing suitable technology and innovations for the function and acting as Business Owner of related...

  • Senior Medical Director

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly experienced Senior Medical Director to lead our Safety Medical Sciences business functions and provide strategic inputs to Safety Services Leadership. As a key member of our team, you will be responsible for implementing suitable technology and innovations for the function and acting as Business Owner of related...

  • Medical Director, Gastrointestinal Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director to join our team in the Gastrointestinal Therapeutic Area. As a Medical Director, you will be responsible for providing medical expertise and leadership to our clients across multiple channels and interactions.Key ResponsibilitiesProject Execution: Deliver medical monitoring activities...

  • Medical Director, Gastrointestinal Specialist

    hace 2 semanas

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director to join our team in the Gastrointestinal Therapeutic Area. As a Medical Director, you will be responsible for providing medical expertise and leadership to our clients across multiple channels and interactions.Key ResponsibilitiesProject Execution: Deliver medical monitoring activities...

  • Medical Director, Gastrointestinal Specialist

    hace 4 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director to join our team. As a medical expert with specialized therapeutic expertise in Gastroenterology, you will play a key role in delivering medical support for our clients.Key ResponsibilitiesProject Execution: Deliver medical monitoring and PV support for contracted projects.Medical Monitoring:...

  • Medical Director

    hace 3 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director with expertise in Hematology and Hematopoietic Stem Cell Transplantation to join our team.Key ResponsibilitiesInitiate and maintain medical and consultative relationships with clientsConsult on early engagement and pre-award effortsServe as a medical monitor for contracted projectsParticipate...

  • Medical Director

    hace 3 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director with expertise in Hematology and Hematopoietic Stem Cell Transplantation to join our team.Key ResponsibilitiesInitiate and maintain medical and consultative relationships with clientsConsult on early engagement and pre-award effortsServe as a medical monitor for contracted projectsParticipate...

  • Medical Director

    hace 4 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director with a strong background in Gastroenterology to join our team. As a medical expert, you will be responsible for providing specialized therapeutic expertise and leading medical and consultative relationships with clients.Key ResponsibilitiesProject Execution: Deliver medical support for...

  • Medical Director

    hace 3 días

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director with a strong background in Gastroenterology to join our team. As a medical expert, you will be responsible for providing specialized therapeutic expertise and leading medical and consultative relationships with clients.Key ResponsibilitiesProject Execution: Deliver medical support for...

  • Senior Medical Advisor

    hace 4 días

    Alcobendas, Madrid, España BeiGene A tiempo completo

    Job Title: Senior Medical AdvisorBeiGene is seeking a highly motivated and experienced Senior Medical Advisor to join our team in North of Spain. As a key member of our Medical Affairs department, you will play a pivotal role in supporting the development and execution of local medical strategies.Key Responsibilities:Establish and maintain credible...

  • Senior Medical Advisor

    hace 3 días

    Alcobendas, Madrid, España BeiGene A tiempo completo

    Job Title: Senior Medical AdvisorBeiGene is seeking a highly motivated and experienced Senior Medical Advisor to join our team in North of Spain. As a key member of our Medical Affairs department, you will play a pivotal role in supporting the development and execution of local medical strategies.Key Responsibilities:Establish and maintain credible...

  • Medical Director, Gastrointestinal Specialist

    hace 1 semana

    Alcobendas, Madrid, España Parexel A tiempo completo

    About the RoleParexel is seeking a highly skilled Medical Director to join our team. As a medical expert with specialized therapeutic expertise in Gastroenterology, you will play a key role in delivering medical support for our clients.Key ResponsibilitiesProject Execution: Medical Monitoring Delivery & PV SupportIndependently deliver all medical support...